Benefits of Individual Physical Activity Intervention on Health-related Quality of Life in Participants With Chronic Lymphocytic Leukemia
NCT ID: NCT06299540
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
180 participants
OBSERVATIONAL
2024-05-27
2027-10-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1: Individual Physical Activity Intervention
Participants with chronic lymphocytic leukemia (CLL) will be invited to perform physical activity according to a predefined intervention program. This program includes walking and weekly remote adapted physical activity sessions (2 sessions per week, the duration and difficulty of which will be adapted by the adapted physical activity \[APA\] trainer according to the Participant's abilities).
Individual Physical Activity Intervention (IPAI)
No drug will be administered as a part of this study. The intervention will consist in an IPAI provided to participants for 6 months to practice physical activity in addition to their medical treatment in routine clinical practice settings. IPAI will be an adaptive program and will comprise two periods, the first period consisting in a supervised 4-month program and the second one in an unsupervised 2-month program to achieve greater autonomy.
Ibrutinib
No drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings.
Group 2: Standard of Care
Participants with CLL will continue physical activity according to their lifestyle and the recommendations of the medical team.
Ibrutinib
No drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings.
Interventions
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Individual Physical Activity Intervention (IPAI)
No drug will be administered as a part of this study. The intervention will consist in an IPAI provided to participants for 6 months to practice physical activity in addition to their medical treatment in routine clinical practice settings. IPAI will be an adaptive program and will comprise two periods, the first period consisting in a supervised 4-month program and the second one in an unsupervised 2-month program to achieve greater autonomy.
Ibrutinib
No drug will be administered as a part of this study. Participants received ibrutinib as per their routine clinical practice settings.
Eligibility Criteria
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Inclusion Criteria
* Participants agreed to follow the individual physical activity intervention (IPAI)
* Participants using or having access to a compatible and appropriate electronic device such as smartphone, laptop or tablet
* Participants with Internet access at home and email address
* Participants agreed to wear a connected watch 24 hours a day for all the duration of the study
Exclusion Criteria
* Participants with inability or deemed unsafe to practice physical activity
* Participants who have received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 90 days before the inclusion visit
* Participants who are currently involved in an interventional study
* Participants with probable difficulties in using the digital tool autonomously
18 Years
ALL
No
Sponsors
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Janssen Cilag S.A.S.
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Cilag S.A.S., France Clinical Trial
Role: STUDY_DIRECTOR
Janssen Cilag S.A.S.
Locations
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Institut Universitaire du Cancer Toulouse Oncopole
Toulouse, , France
Countries
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Central Contacts
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Other Identifiers
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54179060CLL4033
Identifier Type: OTHER
Identifier Source: secondary_id
54179060CLL4033
Identifier Type: -
Identifier Source: org_study_id